CE认证中英文介绍

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1 前言Introduction欧洲议会和欧洲理事会于2006年5月17日正式通过了,产品申请CE认证(CE-Marking即CE标志)的最新版机械指导法令(2006/42/EC),此法令是欧盟按照新方法(New approach)制定的有关健康、安全的基本法令之一。

与现行机械指令98/37/EC相比,新指令在适用范围、与其他指导法令的界线、市场临督、安全性零组件、合格评定程序以及基本健康和安全要求等方而都出现了一些新要求和明显的变化。

European Parliament and European Council have adopted the latest version of the Machinery Directive (2006/42/CE) on 17 May, 2006. This new directive is made according to a new approach; its one of the basic directives on health and safety concern. Compared with the present Machinery Directive 98/37/EC there are some new requirements and noticeable changes to the new one on its application, boundary with other directives, market supervision, safe components, conformity assessment procedure, the requirement for the basic health and safety, etc.面对新的技术壁垒,相关部门和广大企业应提前做好研究,有关欧盟对CE认证(CE-Marking)的新规定,及早从实际应用和技术角度出发加以积极应对。

Faced with the new technical barrier, the departments involved and whole enterprises shall conduct better research in advance to take vigorous action against the new regulations of the CE-marking.新法令由正文和12个附件组成,正文包括:适用机械范围、名词概念定义、市场监督、投放市场和交付使用、合格推定和协调标准、处理潜在危险机械特定措施、协调标准争议的处理程序、防护条款、机械合格性评估程序、机械半成品部分完成机械装置规程、指定认证机构、CE标志、指令95/16/EC的修订说明等29个条款。

附件主要包括:有关机械设计与制造的基本健康与安全要求、机械合格声明的要求、CE标志、执行合格性评定的机械类别目录、安全性元件明细清单、机械半成品部分完成机械装置的组装说明要求、技术文档要求、机械制造过程内部审核的合格性评估、EC型式试验、完善的质量保证规程、各成员指定认证机构时应考虑的最低标准。

The new directive is composed by body of the text and 12 appendixes. The body is composed by 29 clauses including machines applied to the new directive, some concepts and definitions, market supervision, its launch and submission, conformity presumption and adjustment standard, specific measures to deal with machines with potential hazards, dispute settlement procedure, protective covenant, machinery conformity assessment procedure, designated certification authority, CE marking, revision note for directive 95/16/EC, etc. Appendixes mainly include: the basic health and safety requirement to design and manufacture the machinery, declaration for the machinery conformity requirement, CE marking, catalogue for the machinery which need conformity assessment, protectivecomponent list, requirement for the technical documents, internal audit assessment on the machine manufacture, EC test, perfect quality assurance, the minimum standard needs to be considered when each member designates the certification body/authority.整个法令的内容在各方面多加以细化,同时将原98/37/EC指令中阐述相同内容的条款汇总分类组成独立条款,整个法令文件框架更加明确,有助于制造商、认证机构、成员国等相关各方对法令内容的理解和应用。

All aspects of the new directive are more specific in content. Meanwhile, those clauses stated thesame as in the previous directive 98/37/EC are sorted and classified into independent clauses. The framework for the whole directive is more specific which can also help manufacturer, certification authorization/body, member states, etc. understand and apply the directive.2新版机械指导法令的立法依据The Legislation Basis of the New Machinery Directive机械指导法令2006/42/EC是根据新欧盟条约"(EC Treaty)第95条(原条约100条)制定的一系列措施之一,欧盟条约第95条的主要目的是为实现货物和服务的单一欧洲市场而提出的机械安全、健康方面的要求。

新的机械指令的制定同时考虑了来自欧盟委员会的提议以及欧洲经济与社会委员会的意见。

此次修改机械指令的目的是为了提出更好的各种概念的定义,以便澄清相关问题并更好地确保指导法令的统一应用,确保产品在欧盟范围内的自由流通,同时保证在健康、安全和消费者保护方面达到较高的水平。

The new machinery directive 2006/42/EC is one of the serial measures made according to Article 95 of the new EC Treaty (Article 100 in the previous Treaty). The main purpose for Article 95 in the Treaty is for putting forward some requirements on machine safety and health in order to make a single European market for goods and services. The proposal of European Council and suggestion of European Economic and Social Committee are also taken into account when the new machinery directive is established. The amendment for machinery directive is to better put forward all concepts and definitions so as to clarify issues concerned and make sure the better application of the directive, to make sure the free flow of the goods in the European Union countries, and at the same time to ensure that a higher level of health, safety and consumption protection can be reached.最早的机械安全指令是89/392/EEC,9l/368/EEC增加了原来未包括在内的移动机械和和用于装载货物的升降没备。

93/44/EEC增加了电梯指令中未涵盖的载人电梯的要求。

日前的98/37/EC增加了对CE标志、合格声明的文件和资料的规定,同时增加了强制性要求。

新指令2006/42/EC目前已进入生效期,将于2009年12月29日正式实施,其中对便携式弹药推动固定器械和其他冲击式机械的要求延期至2011年7月29日开始施行。

Mobile machinery and lifting appliance used for cargo loading which are excluded in the earliest directive 89/392/EEC were added into the directive 91/368/EEC. The requirement for the passenger elevator was added into the directive 93/44/EEC. The regulations for CE marking, documents and data for conformity declaration and mandatory requirements were added into the present directive 98/37/EC. The new directive 2006/42/EC now is effective and will officially be implemented on 29 Dec. 2009, among which the requirement for the fixed portable cartridge operated devices and other impact machines will be postponed to be put into force on 29 Jul. 2011.3机械安全指令的适用范围及定义The Definition and Application of the Machinery Directive与指令98/37/EC不同,新指令不仅排除了一些机械设备,而且对适用的机械产品也给予了明确的规定。